The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 2 December 2025, approved tisotumab vedotin
(Tivdak) used for the treatment of adults
with cervical cancer that has come back or
spread. It is
used if the disease worsened after previous anti-cancer
treatment.
Tisotumab vedotin is administered via an intravenous
infusion (drip) into the vein over 30 minutes once every three
weeks.
Beach, Interim Executive Director
of Healthcare Quality and Access at the MHRA,
said:
“Patient safety is our top priority.
“The approval of tisotumab vedotin provides a new treatment
option for adults with cervical cancer.
“As with all licensed medicines, we will continue to monitor its
safety closely as it becomes more widely used.”
A full list of side effects can be found in the Patient
Information Leaflet (PIL) or the Summary of Product
Characteristics (SmPC), which will be published on the MHRA
website within 7 days of approval.
The most common side effects include eye problems such as
conjunctivitis and keratitis, and nerve problems such as
numbness, tingling or burning in the hands and feet.
As with any medicine, the MHRA will keep the safety and
effectiveness of tisotumab vedotin under close review. Anyone who
suspects they are having a side effect from this medicine is
encouraged to talk to their doctor, pharmacist or nurse and
report it directly to the MHRA Yellow Card scheme, either through
the website (https://yellowcard.mhra.gov.uk)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
ENDS Notes to
editors
-
The approval was granted on 2 December 2025
to GENMAB AS
-
This medicine has been approved through the International
Recognition Procedure (IRP).
-
More information can be found in the Summary of Product
Characteristics and Patient Information Leaflets which will
be published on the MHRA Products website within 7 days of
approval.
